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AgVetLink December 2004

VICH – update on pharmacovigilance harmonisation

Debbie Morris represented the ANZ VICH Committee at the meeting in Berlin on 19-20 October 2004. Following this meeting, the VICH Steering Committee provided an update on the development of VICH pharmacovigilance.

The Steering Committee reaffirms its commitment to the VICH process and recommends that the Pharmacovigilance Working Group (WG) be reconvened to complete the harmonisation process to deliver mutually agreeable guidelines for adverse event reporting. The Steering Committee recommends four principles to assist the WG in coming to an agreed position:

• Flexibility by WG representatives will be required.

• There must be willingness to negotiate and compromise on five key issues:

1. definitions on similar/identical products for expedited reporting

2. data field requirements

3. common dictionary

4. timelines for expedited reporting

5. timelines for periodic summary update (PSU) reports.

• The VICH Guidelines produced should be an improvement over the status quo.

• Regulators should not overregulate unnecessarily.

The Steering Committee is making the following proposals to the WG:

• Each product should have a single International Birth Date. This would be the first marketing authorisation (registration approval) in any of the VICH represented regions. This is necessary to synchronise the PSU to the product birth date.

• PSUs are subject to local regulatory needs; however, reports based on six-monthly data sets are considered appropriate. Some states wish to have a 12-monthly PSU cycle, provided that the product has been approved for more than two years in a VICH region.

• Clarification of the reporting issues under points 4 and 5 above is required.

• The Steering Committee is committed to seeing a resolution reached on the type of adverse event information, the way it is captured, and the time and method of its transmission to other VICH partners.

• In the data capture area, information should be divided into dispensable (non-mandatory) and indispensable (mandatory) information.

• The adoption of common terminology is seen as central to the implementation of harmonised guidelines.